An observational study in MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and Food Insecurity, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-09-02.
Sponsored by University of California, San Francisco · Observational
This proposal addresses a critical gap in our understanding of the impact of household food insecurity (FI) on pediatric metabolic dysfunction-associated steatotic liver disease (MASLD) severity. There is evidence that children in families that do not have the ability to provide consistently healthy and high-quality foods, such as fruits and vegetables, have worse diet quality that children in households that are food secure. Additionally, evidence from adult studies link household FI to MASLD and liver fibrosis, and prior research of the PI has shown that exposure to household FI in early childhood was associated with a nearly 4 times increased odds of pediatric MASLD in middle childhood. Possible mechanisms linking household FI to pediatric MASLD include lower intake of fruits and vegetables, higher intake of caloric dense nutrient poor foods (e.g., sugar sweetened beverages), and less diversity of foods. Given consensus recommendations for the management of MASLD focus on lifestyle modification, i.e., diet and exercise to achieve weight loss, this proposal seeks to explore the association of household FI and pediatric MASLD disease severity and whether those effects are mediated by dietary intake. Study participants include children/adolescents with MASLD who are receiving care at UCSF's liver clinic and Weight Management for Teen and Child Health (WATCH) Clinic, a pediatric subspecialty clinic.
Metabolic dysfunction-associated steatotic liver disease (MASLD) is now the most common type of chronic liver disease among children and adolescents in the US, with the highest burden among children from low-income families, those with obesity, and those who are Hispanic. MASLD describes a spectrum of liver injury from simple hepatic steatosis to steatohepatitis, which can progress to liver fibrosis, cirrhosis, hepatocellular carcinoma, and liver failure. MASLD is one of the leading indications for liver transplantation in adults. Emerging evidence in adults links household FI to MASLD, liver fibrosis, and mortality. FI is defined by the US Department of Agriculture (USDA) as a state in which there is "limited or uncertain availability of nutritionally adequate and safe foods or limited or uncertain ability to acquire foods in socially acceptable ways." Adults with MASLD and FI have been shown to have poor diet quality that is significantly associated with fibrosis.
Research has found that household FI is highly prevalent in families with children. Fifteen percent of U.S. households, and 30% of San Francisco households with children are food insecure, which limits the ability of these families to consistently provide healthy, high-quality food. Research has found that children living in food insecure households have worse diet quality with regard to specific food categories compared to those in food secure households. Specifically children in food insecure households consume fewer fruits and vegetables (F\&V), and more SSBs. Children in households with severe FI have worse overall diet quality than those who are food secure.
Researchers, including the PI (see preliminary studies below), have found that exposure to household FI in children/adolescents is associated with pediatric MASLD. Given current consensus recommendations for the management of pediatric MASLD focus on lifestyle interventions, i.e., diet and physical activity), this project will assess the association of household FI and MASLD disease severity and whether these effects are mediated by dietary intake.
University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children with MASLD with and without exposure to household food insecurity.
Elevated ALT on at least 2 occasions within the past year:
Exclusion Criteria:
Child has another known cause of liver disease (not including MASLD or MASH), such as:
Children with MASLD with exposure to household food security
Children with MASLD with exposure to household food insecurity
Alanine aminotransferase (ALT)
Alanine aminotransferase (ALT)
Time frame: 30 days
Gamma-glutamyl transferase (GGT)
Gamma-glutamyl transferase (GGT)
Time frame: 30 days
Dietary intake of fruits and vegetables
Dietary intake of fruit and vegetables
Time frame: 30 days
dietary intake of SSBs
Dietary intake of sugar sweetened beverages
Time frame: 30 days
Plan to share: No
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University of California, San Francisco